Events

Expression MR200 MRI Patient Monitoring System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Invivo Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    69192
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0001-2015
  • 사례 시작날짜
    2014-09-08
  • 사례 출판 날짜
    2014-10-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129828
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • 원인
    During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. the metallic debris could affect system performance due to the potential for a failure to power up or loss of power. this could result in the loss of monitoring and a delay in diagnosis of the patient.
  • 조치
    The firm, Philips Healthcare, sent an "URGENT- Medical Device Recall" letter dated June 17, 2014, to its customers informing them of the product, problem and actions taken. The firm informed the customers that there are no additional actions required on their part. The Philips/Invivo Account Manager will contact them in order to arrange for replacement of the device. If you need any further information or support concerning this issue, contact your local Philips/Invivo representative: 877-468-4861 option 1, then option 2.

Device

Expression MR200 MRI Patient Monitoring System
  • 모델명 / 제조번호(시리얼번호)
    Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
  • 제품 설명
    Philips Expression MR200 MRI Patient Monitoring System Model 866120
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • 제조사 주소
    Invivo Corporation, 12151 Research Pkwy, Suite 200, Orlando FL 32826-3222
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA